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July 29-August 2, 2018
, Washington, DC, USA

Related Materials

Related presentations, posters, and scientific talks from this event have been posted here for your reference. Please click the associated link to download.

Applying QbD in Process and Impurity Control Strategy Development, A. Anderson, S.K. Bhal, J. DiMartino, and I. Oshchepkova

Poster Schedule


Applying QbD in Process and Impurity Control Strategy Development
Andrew Anderson, Sanjivanjit K. Bhal, Joe DiMartino, and Irina Oshchepkova
Location: Exhibition Hall C
Poster #: P-T-1201

Abstract: Impurity control management is based on successful separation of impurities from the API, and continuous refinement of methods. Software systems currently available to separations scientists are unable to connect detailed method development data for a drug substance, chromatographic and chemical structure information, and synthetic routes. All of this information must be reviewed together to build effective impurity control strategies. Furthermore, global regulatory authorities continue to push Quality-by-Design (QbD) in pharmaceutical development to support risk management. While QbD affords many important long-term benefits, the expectations are having a dramatic impact on product development groups.

In order to effectively leverage QbD in risk mitigation, organizations should consider informatics platform innovation—particularly to support reduction of data abstraction, data assembly, and human data preparation. Informatics software for impurity control should optimally provide users with the ability to construct 'process maps' which allow for visual comparison of molecular composition across unit operations i.e., to track impurity fates. The platform should also allow the user to visualize the wide variety of related spectroscopic and chromatographic data in a single environment for each stage and substance, and store relevant physicochemical property data per entity, for efficient and informed decision-making.

We will provide an overview of an innovative software application (Luminata™) developed specifically to address these informatics innovation needs.